Local Contract Nurse RN - Clinical Coordinator, Research / Clinical Research
Newport Beach, CA
Apidel Technologies
5x8 hrs, Days
Referral Bonus

Position Summary
The Clinical Research Coordinator RN II (CRC RN-II) manages complex clinical trials (Phase I–IV) across drug, device, biologic, and investigator-initiated studies. This role ensures strict adherence to Good Clinical Practice (GCP), FDA regulations, and human subject protection standards, while coordinating all operational aspects of assigned research protocols.

Key Responsibilities
• Manage Phase I–IV clinical trials (industry-sponsored, government-funded, investigator-initiated)
• Ensure compliance with GCP, FDA, NIH, and OHRP regulations
• Perform protocol review, study start-up, and site initiation activities
• Lead informed consent process and patient education
• Conduct subject recruitment, screening, and eligibility assessments
• Perform clinical assessments and sample collection (IATA compliant)
• Maintain regulatory binders, source documentation, and study files
• Complete case report forms (CRFs) and resolve data queries
• Monitor and report adverse events (AE/SAE)
• Enter and validate data in clinical research databases (EDC systems)
• Participate in monitoring visits, audits, and study meetings
• Support budgeting, cost analysis, and financial tracking of studies
• Mentor junior CRCs and support team development

Required Qualifications
• Active Registered Nurse (RN) license – California
• BLS Certification
• Minimum 2+ years of clinical research experience
• Strong knowledge of:
o Good Clinical Practice (ICH-GCP)
o FDA regulations & human subject protection
o Clinical trial lifecycle & methodologies
• Experience with:
o Protocol review
o Informed consent
o Subject recruitment & screening
o CRFs / EDC / data entry
o Adverse event reporting
o Regulatory documentation (IRB, binders)
• Proficiency in Microsoft Office (Word, PowerPoint)